Impact of Infliximab-dyyb (Infliximab Biosimilar) on Clinical and Patient-Reported Outcomes: 1-Year Follow-up Results from an Observational Real-World Study Among Patients with Inflammatory Bowel Disease in the US and Canada (the ONWARD Study)

Abstract

Introduction: To date, there are limited realworld studies published on the use of infliximab-dyyb, a biosimilar to reference product (RP) infliximab approved for the treatment of moderate to severe inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC) in North America. This study examined utilization patterns and the effects of infliximab-dyyb on clinical outcomes, patient-reported outcomes (PROs), and healthcare resource use (HCRU) in IBD patients in a real-world setting. Methods: In this prospective, observational study, adult IBD patients in the US and Canada were recruited to initiate treatment with infliximab-dyyb and followed for 12 months. Patients included biologic-naı ¨ve users of infliximab-dyyb and patients switching from RP infliximab or other biologics to infliximabdyyb. Partial Mayo (pMAYO) and Harvey Bradshaw Index (HBI) scores measured clinical outcomes for the UC and CD cohorts, respectively. Key PRO measures included the SIBDQ, EQ-VAS, and psychological outcomes. In addition, work productivity, HCRU, and adverse events (AEs) were assessed.

Characteristics and 6-Month Outcomes in Patients with Rheumatoid Arthritis Initiating Infliximab Biosimilar IFX-dyyb in a Real-World Setting

“…IFX-dyyb (CT-P13; Inflectra ® ) is a biosimilar of Remicade ® (IFX-REF) [ 7 ]. Randomized controlled trials and studies using real-world data have shown comparable clinical outcomes for IFX-dyyb as for IFX-REF in RA [ 8 – 11 ], AS [ 12 , 13 ], Crohn’s disease [ 14 ], and UC [ 14 , 15 ].…”